Background: In recent years many therapeutic regimens have been designed in order to improve response rate and response duration in non-Hodgkin's lymphoma (NHL). In 1991 the Italian Lymphoma Study Group (GISL) started a prospective randomized trial on treatment of aggressive and advanced NHL, focused on the efficacy of two Pro-MACE-CytaBom (P-C) derived protocols.
Methods: From April 1991 to March 1993, 243 cases of intermediate and high grade NHL (Groups D-H according to the Working Formulation) in stage I bulky, II-IV have been registered from 19 institutions and randomized to receive 6 courses of either epidoxorubicin, 30 mg/m2 (P-E) or idarubicin, 6 mg/m2 (P-I) containing P-C. The present study deals with the results of an interim analysis of the first 96 cases enrolled up to December 1991 (median follow up of surviving cases 19 months, range 15-23), in terms of overall response rate, toxicity and dose intensity of the two schedules, and overall survival.
Results: The overall response rate was: 55 CR (64.0%), 15 PR (17.4%), 5 NR (5.8%) and 11 PG (12.8%). The actuarial survival rate was 61% at 24 months. Hematological and non-hematological toxicity was comparable in the two arms. Dose intensity was high and similar for the two schedules (90% vs 89%).
Conclusion: This interim analysis demonstrates that in aggressive NHL both P-C derived schedules with epidoxorubicin or idarubicin are effective, safe and well tolerated, also when used in a large multicentric setting.